Minghui Pharmaceutical Inc. Achieves Breakthrough with MH004 Cream: Clinically Proven Best-in-Class Topical Treatment for Atopic Dermatitis Receives FDA Clearance for Global Phase 3 MRCT

Minghui Pharmaceutical, Inc. is thrilled to share top line results from its Phase 2 study of MH004 Cream, a topical cream of a pan-JAK inhibitor, for treating mild-to-moderate atopic dermatitis (AD) in adolescents and adults.

The study achieved its primary endpoint of mean percentage changes from baseline in EASI score and key secondary endpoints, including IGA-TS and EASI-75 response. This is an exciting breakthrough for those suffering from AD, providing a promising new treatment option.

The study was an exciting Phase 2 multi-center, double blind, vehicle-controlled proof-of-concept study that included 150 adolescents and adults with mild-to-moderate AD. Participants were randomized to receive twice daily topical applications of vehicle, 0.3% or 1.0% MH004 Cream for 4 weeks and the efficacy, safety, tolerability, and pharmacokinetics (PK) were assessed. The study aimed to determine the effectiveness of two concentrations of the MH004 Cream on individuals with AD covering 3% to 20% of body surface area (BSA) at baseline.

The study was highly successful, as evidenced by the significant results of the primary and secondary endpoints evaluated. After a 4-week treatment with 1.0% MH004 Cream, the mean percentage change in the EASI score was -78.7%, compared to -46.7% for the vehicle (p=0.0003).

Additionally, the efficacy measured by EASI-75 response was 79.6% for the treatment, compared to 42.0% for the vehicle (p<0.0001), and IGA-TS response was 46.9%, compared to 20.0% for the vehicle (p = 0.0011). These results demonstrate the impressive efficacy of 1.0% MH004 Cream.

MH004 Cream was safely administered among study participants, with 98% completing the full study. There were no Serious Adverse Events (SAEs) reported, and only one discontinuation due to a Treatment Emergent Adverse Event (TEAE) in the 1.0% MH004 Cream group compared to five in the vehicle group. All TEAEs were mild, with no Grade 3 or 4 events reported. This highlights the excellent tolerability of MH004 Cream.

Minghui Pharmaceutical is thrilled to announce the promising results of their proof-of-concept study for MH004 Cream, a topical cream containing a JAK inhibitor. This product was created using proprietary technology and formulation, leading to improved penetration of low protein binding molecules into multiple layers of skin. This allowed for a higher free drug concentration in the local skin tissues, as well as a reduction in systemic exposure.

The clinical efficacy of MH004 Cream was impressive and side effects were minimal, making it a potential best-in-class treatment. With these positive results, Minghui Pharmaceutical plans to continue development of MH004 Cream for atopic dermatitis and other dermatological diseases.

We are delighted to announce that the FDA has granted approval for our Phase 3 MRCTs following successful communication and IND submission. Our team is thrilled to be one step closer to initiating Phase 3 studies and forging potential partnerships. As Dr. Guoqing Cao pointed out, “We are delighted with the progress we have made so far and are excited to move forward with this important milestone.”

Dr. Kim Papp, a renowned member of the College of Physicians and Surgeons of Ontario, the Royal College of Physicians and Surgeons of Canada, and the American Academy of Dermatology, is impressed with the Phase 2 results of MH004 Cream – a revolutionary topical therapy that marks an exciting advancement in the treatment of dermatological diseases.

Its unique pharmacological properties make it a particularly effective treatment for conditions like alopecia areata, vitiligo, and prurigo nodularis, which have intact skin barriers.

About MH004 Cream

Minghui’s revolutionary topical cream, MH004 Cream, is designed to revolutionize the treatment of multiple dermatologic autoimmune diseases such as atopic dermatitis. Utilizing their proprietary technologies, MH004 Cream contains a JAK inhibitor that is expected to have much improved skin permeability, allowing for extensive target inhibition in local skin tissues without the systemic toxicities that are associated with oral JAK inhibitor treatments. This cutting-edge cream promises to be a breakthrough in treating these diseases with minimal side effects.

About Atopic Dermatitis

Atopic Dermatitis (AD) is a chronic and recurrent skin disorder that affects a significant proportion of people in developed countries – up to 20% of children, and nearly 10% of adults. It is an incredibly complex condition, caused by a combination of genetic predisposition, impaired skin barrier function, an imbalance of immunity, and environmental factors.

What makes AD even more challenging is that it can lead to disruptions in sleep, reduced work productivity, and even mental health issues such as depression, exacerbating the burden on patients and their families.

About Minghui Pharmaceutical

Minghui Pharmaceutical Inc. is revolutionizing the world of medicine with its groundbreaking biopharmaceuticals. Its clinical-stage pipeline is packed with innovative, first-in-class or best-in-class product candidates, the most promising of which is MH004 Cream.

This revolutionary topical treatment has the potential to become the go-to solution for patients suffering from mild-to-moderate atopic dermatitis and other dermatological disorders. With Minghui Pharmaceutical Inc., the future of healthcare looks brighter than ever.

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